BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 23151889 · Received September 25, 2025

    Report

    Report Number
    3009862700-2025-01452
    Event Type
    Injury
    Date Received
    September 25, 2025
    Date of Event
    June 1, 2025
    Report Date
    September 25, 2025
    Manufacturer
    SENSEONICS INC.
    Product Code
    SBA
    PMA / PMN Number
    P160048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SENSOR WAS INSERTED BY MAKING A SMALL INCISION AND PLACING IT UNDER SKIN, AND THE POTENTIAL FOR DEVELOPING SKIN IRRITATION/INFLAMMATION/INFECTION AT THE INSERTION SITE IS A KNOWN ANTICIPATED ADVERSE EVENT.THE REPORTED SKIN IRRITATION DESCRIBED AS RAW AND PATCH-SIZED AT THE ADHESIVE SITE, FIRST NOTED ON 01-JUN-2025. THE ADHESIVE PATCHES WERE WITHIN EXPIRATION DATE (10-OCT-2027). THE USER WAS USING BANDAGE/TEGADERM AND APPLIES LOTIONS/CREAMS TO THE AREA, WITH A HISTORY OF SENSITIVE SKIN. THE HCP WAS INFORMED AND PRESCRIBED BENADRYL AND BACTRIM. PER DMS, THE USER CONTINUES TO USE THE SYSTEM WITH UP-TO-DATE INFORMATION.

    Description of Event or Problem · 0

    SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE REPORTED SKIN IRRITATION DESCRIBED AS RAW AND PATCH-SIZED AT THE ADHESIVE SITE, FIRST NOTED ON 01-JUN-2025. THE ADHESIVE PATCHES WERE WITHIN EXPIRATION DATE (10-OCT-2027). THE USER WAS USING BANDAGE/TEGADERM AND APPLIES LOTIONS/CREAMS TO THE AREA, WITH A HISTORY OF SENSITIVE SKIN. THE HCP WAS INFORMED AND PRESCRIBED BENADRYL AND BACTRIM. PER DMS, THE USER CONTINUES TO USE THE SYSTEM WITH UP-TO-DATE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311250 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR SBA SENSEONICS INC. 103606-600 01E362S

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female